{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Toronto, Ontario",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "135-2 The W. Mall",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "JHT",
      "openfda": {
        "registration_number": [
          "",
          "3005174594",
          "2517506",
          "2029372",
          "2246703",
          "3010825766"
        ],
        "fei_number": [
          "",
          "1000306617",
          "3005174594",
          "2517506",
          "2246703",
          "3010825766"
        ],
        "device_name": "Chromatographic Separation, Cpk Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      },
      "zip_code": "M9C 1C2",
      "applicant": "Spectral Diagnostics, Inc.",
      "decision_date": "2002-09-30",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST",
      "advisory_committee": "CH",
      "contact": "NISAR A SHAIKH",
      "expedited_review_flag": "",
      "k_number": "K022409",
      "state": "",
      "date_received": "2002-07-24",
      "review_advisory_committee": "CH",
      "postal_code": "M9C 1C2",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}